Arsenal Deformity Spinal Fixation System

GUDID 00840967120348

ILIAC BOLT, 30 DEGREE, 6.5mm X 55mm

ALPHATEC SPINE, INC.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00840967120348
• NIH Device Record Key: b8c748a9-7043-4dd2-80e0-b271d9b496da
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Arsenal Deformity Spinal Fixation System
• Version Model Number: 48700-030-065-055
• Company DUNS: 602465783
• Company Name: ALPHATEC SPINE, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com

Device Dimensions

• Length: 55 Millimeter
• Angle: 30 degree
• Outer Diameter: 6.5 Millimeter
• Length: 55 Millimeter
• Angle: 30 degree
• Outer Diameter: 6.5 Millimeter
• Length: 55 Millimeter
• Angle: 30 degree
• Outer Diameter: 6.5 Millimeter
• Length: 55 Millimeter
• Angle: 30 degree
• Outer Diameter: 6.5 Millimeter
• Length: 55 Millimeter
• Angle: 30 degree
• Outer Diameter: 6.5 Millimeter
• Length: 55 Millimeter
• Angle: 30 degree
• Outer Diameter: 6.5 Millimeter
• Length: 55 Millimeter
• Angle: 30 degree
• Outer Diameter: 6.5 Millimeter
• Length: 55 Millimeter
• Angle: 30 degree
• Outer Diameter: 6.5 Millimeter
• Length: 55 Millimeter
• Angle: 30 degree
• Outer Diameter: 6.5 Millimeter
• Length: 55 Millimeter
• Angle: 30 degree
• Outer Diameter: 6.5 Millimeter
• Length: 55 Millimeter
• Angle: 30 degree
• Outer Diameter: 6.5 Millimeter
• Length: 55 Millimeter
• Angle: 30 degree
• Outer Diameter: 6.5 Millimeter
• Length: 55 Millimeter
• Angle: 30 degree
• Outer Diameter: 6.5 Millimeter
• Length: 55 Millimeter
• Angle: 30 degree
• Outer Diameter: 6.5 Millimeter
• Length: 55 Millimeter
• Angle: 30 degree
• Outer Diameter: 6.5 Millimeter
• Length: 55 Millimeter
• Angle: 30 degree
• Outer Diameter: 6.5 Millimeter
• Length: 55 Millimeter
• Angle: 30 degree
• Outer Diameter: 6.5 Millimeter
• Length: 55 Millimeter
• Angle: 30 degree
• Outer Diameter: 6.5 Millimeter
• Length: 55 Millimeter
• Angle: 30 degree
• Outer Diameter: 6.5 Millimeter
• Length: 55 Millimeter
• Angle: 30 degree
• Outer Diameter: 6.5 Millimeter
• Length: 55 Millimeter
• Angle: 30 degree
• Outer Diameter: 6.5 Millimeter
• Length: 55 Millimeter
• Angle: 30 degree
• Outer Diameter: 6.5 Millimeter
• Length: 55 Millimeter
• Angle: 30 degree
• Outer Diameter: 6.5 Millimeter
• Length: 55 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840967120348 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152968

FDA Product Code

• MNH: Orthosis, spondylolisthesis spinal fixation
• OSH: Pedicle screw spinal system, adolescent idiopathic scoliosis

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00840967120348]

Moist Heat or Steam Sterilization

[00840967120348]

Moist Heat or Steam Sterilization

[00840967120348]

Moist Heat or Steam Sterilization

[00840967120348]

Moist Heat or Steam Sterilization

[00840967120348]

Moist Heat or Steam Sterilization

[00840967120348]

Moist Heat or Steam Sterilization

[00840967120348]

Moist Heat or Steam Sterilization

[00840967120348]

Moist Heat or Steam Sterilization

[00840967120348]

Moist Heat or Steam Sterilization

[00840967120348]

Moist Heat or Steam Sterilization

[00840967120348]

Moist Heat or Steam Sterilization

[00840967120348]

Moist Heat or Steam Sterilization

[00840967120348]

Moist Heat or Steam Sterilization

[00840967120348]

Moist Heat or Steam Sterilization

[00840967120348]

Moist Heat or Steam Sterilization

[00840967120348]

Moist Heat or Steam Sterilization

[00840967120348]

Moist Heat or Steam Sterilization

[00840967120348]

Moist Heat or Steam Sterilization

[00840967120348]

Moist Heat or Steam Sterilization

[00840967120348]

Moist Heat or Steam Sterilization

[00840967120348]

Moist Heat or Steam Sterilization

[00840967120348]

Moist Heat or Steam Sterilization

[00840967120348]

Moist Heat or Steam Sterilization

[00840967120348]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-06-30
• Device Publish Date: 2016-04-27

On-Brand Devices [Arsenal Deformity Spinal Fixation System]

• 00190376006147: Rod Connector, Closed 5.5mm Side-Loading 6.35mm
• 00190376006130: Rod Connector, Closed 5.5mm Side-Loading 5.5
• 00840967116945: ILIAC BOLT, 15 DEGREE, 9.0mm X 130mm
• 00840967116938: ILIAC BOLT, 15 DEGREE, 9.0mm X 125mm
• 00840967116921: ILIAC BOLT, 15 DEGREE, 9.0mm X 120mm
• 00840967116914: ILIAC BOLT, 15 DEGREE, 9.0mm X 115mm
• 00840967116907: ILIAC BOLT, 15 DEGREE, 9.0mm X 110mm
• 00840967116891: ILIAC BOLT, 15 DEGREE, 9.0mm X 105mm
• 00840967116884: ILIAC BOLT, 15 DEGREE, 9.0mm X 100mm
• 00840967116877: ILIAC BOLT, 15 DEGREE, 9.0mm X 95mm
• 00840967116860: ILIAC BOLT, 15 DEGREE, 9.0mm X 90mm
• 00840967116853: Iliac Bolt, 15°, 9.0mm X 90mm
• 00840967116846: ILIAC BOLT, 15 DEGREE, 9.0mm X 80mm
• 00840967116839: Iliac Bolt, 15°, 9.0mm X 80mm
• 00840967116822: ILIAC BOLT, 15 DEGREE, 9.0mm X 70mm
• 00840967116815: Iliac Bolt, 15°, 9.0mm X 70mm
• 00840967116808: ILIAC BOLT, 15 DEGREE, 9.0mm X 60mm
• 00840967116792: Iliac Bolt, 15°, 9.0mm X 60mm
• 00840967116785: Iliac Bolt, 15°, 9.0mm X 55mm
• 00840967116778: ILIAC BOLT, 15 DEGREE, 9.0mm X 45mm
• 00840967116761: Iliac Bolt, 15°, 9.0mm X 45mm
• 00840967116754: Iliac Bolt, 15°, 9.0mm X 40mm
• 00840967116747: Iliac Bolt, 15°, 9.0mm X 35mm
• 00840967116730: ILIAC BOLT, 15 DEGREE, 8.5mm X 130mm
• 00840967116723: Iliac Bolt, 15°, 8.5mm X 130mm
• 00840967116716: Iliac Bolt, 15°, 8.5mm X 125mm
• 00840967116709: Iliac Bolt, 15°, 8.5mm X 120mm
• 00840967116693: Iliac Bolt, 15°, 8.5mm X 115mm
• 00840967116686: Iliac Bolt, 15°, 8.5mm X 110mm
• 00840967116679: Iliac Bolt, 15°, 8.5mm X 105mm
• 00840967116662: ILIAC BOLT, 15 DEGREE, 8.5mm X 95mm
• 00840967116655: Iliac Bolt, 15°, 8.5mm X 95mm
• 00840967116648: Iliac Bolt, 15°, 8.5mm X 90mm
• 00840967116631: Iliac Bolt, 15°, 8.5mm X 85mm
• 00840967116624: Iliac Bolt, 15°, 8.5mm X 80mm
• 00840967116617: Iliac Bolt, 15°, 8.5mm X 75mm
• 00840967116600: Iliac Bolt, 15°, 8.5mm X 70mm
• 00840967116594: Iliac Bolt, 15°, 8.5mm X 65mm
• 00840967116587: ILIAC BOLT, 15 DEGREE, 8.5mm X 55mm
• 00840967116570: ILIAC BOLT, 15 DEGREE, 8.5mm X 50mm
• 00840967116563: ILIAC BOLT, 15 DEGREE, 8.5mm X 45mm
• 00840967116556: ILIAC BOLT, 15 DEGREE, 8.5mm X 40mm
• 00840967116549: ILIAC BOLT, 15 DEGREE, 8.5mm X 35mm
• 00840967116532: ILIAC BOLT, 15 DEGREE, 8.5mm X 30mm
• 00840967116525: ILIAC BOLT, 15 DEGREE, 8.0mm X 130mm
• 00840967116518: ILIAC BOLT, 15 DEGREE, 8.0mm X 125mm
• 00840967116501: ILIAC BOLT, 15 DEGREE, 8.0mm X 120mm
• 00840967116495: ILIAC BOLT, 15 DEGREE, 8.0mm X 115mm
• 00840967116488: ILIAC BOLT, 15 DEGREE, 8.0mm X 110mm
• 00840967116471: ILIAC BOLT, 15 DEGREE, 8.0mm X 105mm